Job Description

Career Category Clinical Development

Increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product's lifecycle. CfOR scientists partner with internal stakeholders and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines.
We are seeking a Senior Associate, Strategic Planning & Operations, to join the Center for Observational Research (CfOR). This role will work with other Amgen teams to oversee and drive execution of CfOR's operational projects and non-interventional studies ensuring timely completion within budget and at the highest quality. This role requires strong project management capabilities combined with a growth mindset and openness to leveraging emerging AI tools to improve productivity and drive CfOR-wide initiatives.
Key Responsibilities:

• Provide specialized support to a team of Observational Research Scientists specializing in real-world evidence projects in multiple regions
• Provide comprehensive document requirement support, mainly to a team of Observational Research Scientists specializing in real-world evidence studies across the globe
• Support adoption and integration of platforms such as Smartsheet, AI, Microsoft Teams, and Miro to enhance team collaboration and project tracking
• Support strategic initiatives, including operational pilots, change management efforts that elevate CfOR's organizational capabilities
• Contribute to department/unit by ensuring quality of tasks/services provided?
• Communicate status and issues effectively to appropriate parties, both within CfOR and across Amgen
• Assist leaders with study start-up and study close-out processes?
• Identify and implement process improvements through automated technology to increase efficiency, reduce cycle time and replace manual operations
• Create, analyze, and maintain process flow diagrams to ensure efficient and effective operational workflows
• Track and reconcile study milestones and deliverables, ensuring accurate data population in internal systems
• Conduct regular meetings with study leads to discuss operational activities
• Identify potential department/cross functional process improvement activities
• Execute financial transactions, including purchase order processing, invoice verification, payment processing, and engaging with other functions to help plan and manage resource expenses, using Anaplan, Ariba or SAP software

Basic Qualifications:

• Bachelor's degree and 6+ years of Scientific or Operations experience OR
• Master's degree and 4+ years of Scientific or Operations experience

Preferred Qualifications/Skills:

• Minimum of 3 years of project management experience, with 2+ years in pharma/biotech within regulated, cross-functional environments
• Hands-on experience with budgeting, vendor management, and regulated document management systems
• Demonstrates autonomy and reliability in managing tasks and contributing to team goals
• Highly organized, with the ability to prioritize and deliver on projects independently or collaboratively
• Quick learner with strong analytical skills and adaptability to new tools and concepts
• Effective communicator with strong written, verbal, and presentation abilities
• Builds positive relationships and fosters collaboration with a proactive, "can-do" attitude
• Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot, Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.)
• Familiarity with drug commercialization & business practices
• Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations

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Skills Required